Recall Z-0391-2019— Oscor, Inc.

Name: FDA recall Z-0391-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-26

Class I · Terminated

Class I FDA medical device recall by Oscor, Inc., initiated 2018-09-26, terminated 2022-08-04. It names 2 FDA 510(k) clearances: K884866, K861403. Product: TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.. Reason: During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system..

Recalling firm: Oscor, Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-09-26
Terminated: 2022-08-04
Firm location: Palm Harbor, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K884866 — TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1Oscor Medical Corp.·cleared 1989-03-22
K861403 — TB SERIES BIPOLAR PACING LEADSOscor Medical Corp.·cleared 1986-06-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

Reason for recall

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

Data sourced from openFDA. This site is unofficial and independent of the FDA.